SIRION Lateral Lumbar Interbody Fusion

K202495 · Astura Medical, LLC · MAX · Jan 6, 2021 · Orthopedic

Device Facts

• Record ID: K202495
• Device Name: SIRION Lateral Lumbar Interbody Fusion
• Applicant: Astura Medical, LLC
• Product Code: MAX · Orthopedic
• Decision Date: Jan 6, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SIRION Lateral Lumbar Interbody System Spacer, either used individually or assembled to the SIRION plate, is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). SIRION Spacers are to be used with autogenous bone graft and supplemental fixation. Approved supplemental fixation includes the Olympic Posterior System. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. The SIRION Lateral Lumbar Interbody System Plate, in 2-hole configurations, is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of: fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery. The SIRION Lateral Lumbar Interbody System Plate, 1-hole buttress configuration is intended for use in conjunction with traditional supplemental fixation to maintain the relative position of interbody spacers during spinal fusion. The 1-hole plate is not intended for use in load-bearing applications. Hyperlordotic interbody devices (>20° lordosis) must be used in conjunction with the SIRION plate for fixation.

Device Story

System consists of intervertebral body fusion spacers and plates; implants substitute autogenous bone graft blocks to facilitate arthrodesis. Spacers feature hollow centers for bone graft placement; open superior/inferior surfaces allow graft-to-vertebral endplate contact. Used in lateral, anterolateral, or anterior surgical approaches; requires supplemental fixation. Plates stabilize interbody spacers; 1-hole buttress configuration maintains spacer position; hyperlordotic devices (>20°) require plate fixation. Operated by surgeons in clinical/hospital settings. Benefits include avoidance of bone graft donor site complications (e.g., pain, hematoma, infection).

Clinical Evidence

No clinical studies were performed. Substantial equivalence is supported by bench testing only.

Technological Characteristics

Materials: PEEK-OPTIMA LT120HA (MAF 2227), Tantalum (ASTM F560), Titanium Alloy (ASTM F136), Nitinol (ASTM F2063). Mechanical testing per ASTM F2077 (compression/shear) and ASTM F2267 (subsidence). System includes spacers and plates in various footprints/heights. Non-active, implantable device.

Indications for Use

Indicated for skeletally mature patients with lumbar degenerative disc disease (DDD) at one or two contiguous levels (L1-S1), including those with up to Grade I spondylolisthesis or retrolisthesis. Also indicated for thoracolumbar/lumbar spine instability due to fracture, tumor, scoliosis, lordosis, spinal stenosis, or failed previous surgery. Requires 6 months of prior non-operative treatment.

Regulatory Classification

Identification

An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.

Special Controls

*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• Sirion Lateral Lumbar Interbody Fusion (K192006)
• Half Dome (K152512, K163481, K172947, K182877)
• ATEC ALIF and LLIF Spacer System (K182746)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the name. The overall design is clean and professional, reflecting the agency's role in regulating food and drugs.

January 6, 2021

Astura Medical Parker Kelch Quality Manager 4949 W Royal Ln Irving, Texas 75063

Re: K202495

Trade/Device Name: SIRION Lateral Lumbar Interbody Fusion Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD, MAX Dated: December 7, 2020 Received: December 8, 2020

Dear Parker Kelch:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

{1}------------------------------------------------

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K202495 Page 1 of 1

Device Name SIRION LATERAL LUMBAR INTERBODY SYSTEM

Indications for Use (Describe)

The SIRION Lateral Lumbar Interbody System Spacer, either used individually or assembled to the SIRION plate, is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). SIRION Spacers are to be used with autogenous bone graft and supplemental fixation. Approved supplemental fixation includes the Olympic Posterior System. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The SIRION Lateral Lumbar Interbody System Plate, in 2-hole configurations, is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of: fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery.

The SIRION Lateral Lumbar Interbody System Plate, 1-hole buttress configuration is intended for use in conjunction with traditional supplemental fixation to maintain the relative position of interbody spacers during spinal fusion. The 1-hole plate is not intended for use in load-bearing applications.

Hyperlordotic interbody devices (>20° lordosis) must be used in conjunction with the SIRION plate for fixation.

| Type of Use (Select one or both, as applicable) | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| <table><tr><td><span> <span style="text-decoration: underline;"> <svg class="bi bi-check-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> <path d="M10.97 4.97a.75.75 0 0 1 1.071 1.05l-3.992 4.99a.75.75 0 0 1-1.08.02L4.324 8.384a.75.75 0 1 1 1.06-1.06l2.094 2.093 3.473-4.425a.75.75 0 0 1 1.08-.022z" fill-rule="evenodd"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </span></td><td><span> Over-The-Counter Use (21 CFR 801 Subpart C)</span></td></tr></table> | <span> <span style="text-decoration: underline;"> <svg class="bi bi-check-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> <path d="M10.97 4.97a.75.75 0 0 1 1.071 1.05l-3.992 4.99a.75.75 0 0 1-1.08.02L4.324 8.384a.75.75 0 1 1 1.06-1.06l2.094 2.093 3.473-4.425a.75.75 0 0 1 1.08-.022z" fill-rule="evenodd"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
| <span> <span style="text-decoration: underline;"> <svg class="bi bi-check-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> <path d="M10.97 4.97a.75.75 0 0 1 1.071 1.05l-3.992 4.99a.75.75 0 0 1-1.08.02L4.324 8.384a.75.75 0 1 1 1.06-1.06l2.094 2.093 3.473-4.425a.75.75 0 0 1 1.08-.022z" fill-rule="evenodd"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> Over-The-Counter Use (21 CFR 801 Subpart C)</span> | |

**CONTINUE ON A SEPARATE PAGE IF NEEDED.**

This section applies only to requirements of the Paperwork Reduction Act of 1995.

***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.***

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

[e-mail]

*"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."*

{3}------------------------------------------------

## 510(k) Summary: SIRION Lateral Lumbar Interbody Fusion

| Date Prepared | August 28, 2020 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By | Astura Medical<br>4949 W Royal Ln.<br>Irving, TX 75063 |
| Contact | Parker Kelch<br>4949 W Royal Ln.<br>Irving, TX 75063<br>Phone: [phone] x503<br>Email: [e-mail] |
| Trade Name | SIRION Lateral Lumbar Interbody Fusion |
| Common Name | Intervertebral body fusion device |
| Classification Name | Intervertebral body fusion device - lumbar |
| Class | II |
| Product Code | OVD, MAX |
| CFR Section | 21 CFR section 888.3080 |
| Device Panel | Orthopedic |
| Primary Predicate Device | Sirion Lateral Lumbar Interbody Fusion (K192006) |
| Additional Predicate<br>Device(s) | Half Dome (K152512, K163481, K172947, K182877)<br>ATEC ALIF and LLIF Spacer System (K182746) |
| Device Description | The Sirion Lateral Lumbar Interbody devices are implants developed for<br>the substitution of the classical autogenous bone graft blocks. The cages<br>assist to avoid complications related to the bone graft donation site<br>(chronic pain, hematoma, infection, bone removal from the donor site<br>making it impossible to remove bone again, quality of the iliac bone,<br>accessing a healthy donor site that may become an unhealthy site,<br>hernias by the incision). They are available in a range of footprints and<br>heights to suit the individual pathology and anatomical conditions of the<br>patient. The implants have a hollow center to allow placement of<br>autogenous bone graft. The superior and inferior surfaces are open to<br>promote contact of the bone graft with the vertebral end plates, allowing<br>bone growth (arthrodesis). The Sirion cages are designed to be used in<br>conjunction with supplemental spinal fixation instrumentation. |
| Materials | PEEK-OPTIMA LT120HA (PEEK-OPTIMA HA Enhanced) – MAF 2227<br>Tantalum per ASTM F560<br>Titanium Alloy (Ti6-AL4-V ELI) per ASTM F136<br>Nitinol #1 (ASTM F2063) |
| Indications for Use | The SIRION Lateral Lumbar Interbody System Spacer, either used<br>individually or assembled to the SIRION plate, is indicated for<br>intervertebral body fusion procedures in skeletally mature patients with<br>degenerative disc disease (DDD) of the lumbar spine at one or two<br>contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic pain |
| with degeneration of the disc confirmed by history and radiographic<br>studies. These DDD patients may also have up to Grade I spondylolisthesis<br>or retrolisthesis at the involved level(s). SIRION Spacers are to be used<br>with autogenous bone graft and supplemental fixation. Approved<br>supplemental fixation includes the Olympic Posterior Spinal Fixation<br>System. Patients should have at least six (6) months of non-operative<br>treatment prior to treatment with an intervertebral cage. | |
| The SIRION Lateral Lumbar Interbody System Plate, in 2-hole and 4-hole<br>configurations, is indicated for use via a lateral or anterolateral surgical<br>approach above the bifurcation of the great vessels in the treatment of<br>thoracic and thoracolumbar (T1-L5) spine instability or via the anterior<br>surgical approach, below the bifurcation of the great vessels in the<br>treatment of lumbar and lumbosacral (L1-S1) spine instability as a result<br>of: fracture (including dislocation and subluxation), tumor, degenerative<br>disc disease (defined as back pain of discogenic origin with degeneration<br>of the disc confirmed by patient history and radiographic studies),<br>scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine<br>surgery. | |
| The SIRION Lateral Lumbar Interbody System Plate, 1-hole buttress<br>configuration is intended for use in conjunction with traditional<br>supplemental fixation to maintain the relative position of interbody<br>spacers during spinal fusion. The 1-hole plate is not intended for use in<br>load-bearing applications | |
| Hyperlordotic interbody devices (>20° lordosis) must be used in<br>conjunction with the SIRION plate for fixation. | |
| Non-clinical Test<br>Summary | The following analyses were conducted:<br>• FEA<br>○ Static and Dynamic Compression (ASTM F2077)<br>○ Static and Dynamic Shear (ASTM F2077)<br>○ Subsidence (ASTM F2267)<br>• Mechanical<br>○ Expulsion |
| | The results of these evaluations indicate that the Sirion implants are<br>equivalent to predicate devices. |
| Clinical Test Summary | No clinical studies were performed |
| Substantial Equivalence | Astura Medical considers the Sirion Lateral Lumbar Interbody System to<br>be equivalent to the predicate devices listed above. This conclusion is<br>based upon the devices' similarities in principles of operation, technology,<br>materials and indications for use. |

In accordance with 21 CFR 807.92 of the Federal Code of Regulations

{4}------------------------------------------------